STEERLife, the life sciences division of India-based STEER World, and Bionpharma Inc, a US-based pharmaceutical company, announced on Tuesday that Bionpharma has received Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (FDA) for its generic Etravirine tablets.
The product, a second-line antiretroviral therapy for the treatment of HIV/AIDS, was developed using STEERLife's proprietary FragMelt continuous processing platform which enables a sustainable, solvent-free manufacturing route while maintaining strict bioequivalence to the reference product, INTELENCE.
This approval enables Bionpharma to commercialise the product in the United States, expanding patient access to a high-quality, more affordable treatment option for HIV/AIDS.
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